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临床试验/NCT05233423
NCT05233423已完成不适用

The Effect of Pressurized Cold Application on Pain Level in Patients Wıth Total Knee Prosthesis Surgery

Pamukkale University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
The change in pain level of total knee prothesis patients at 9 cold applicatiıon with Visual Analog Scale.

研究概览

简要总结

This study was conducted to examine the effects of pressurized cold applicatıon for patients total knee prosthesis surgery.

详细描述

The study was conducted as a randomized controlled experimental study in order to determine the effect of pressurized cold application applied after total knee replacement surgery on the level of pain and satisfaction.This study was conducted in 52 patients who applied to Pamukkale University Hospitals Orthopedics and Traumatology Clinic between July 2019 and February 2020, who met the inclusion criteria and accepted to participate in the study. The patients were divided into 26 in the control group (cold gel) and 26 in the study group (compressed cold therapy bandage) using a simple randomization method. The patients in the control group received 9 cold applications, in the form of 20 minutes of application and 40 minutes of rest after surgery. The patients in the study group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Single blinding was provided that included inclusion criteria and agreement to participate in the study.

入排标准

年龄范围
46 Years 至 82 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18 Years and older
  • •TDP surgery is planned to be performed by the same physician according to the rapid recovery protocol
  • •volunteer to participate in research
  • •had no problems in communicating cognitively, emotionally and verbally were included.

排除标准

  • •have a cold allergy
  • •have peripheral vascular disease
  • •diagnosed with Raynaud's disease
  • •have cognitive, affective and verbal communication problems

研究组 & 干预措施

Intervention Group

Experimental

The patients in the intervention group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.

干预措施: compressed cold therapy bandage (Device)

Control Group

No Intervention

The patients in the control group were applied 9 times of cold gel in the form of 20 minutes of application and 40 minutes of rest after surgery.

结局指标

主要结局

The change in pain level of total knee prothesis patients at 9 cold applicatiıon with Visual Analog Scale.

时间窗: According to the fast track protocol, a total of 9 cold applications were applied to the patients who stayed in the service for an average of 1 day after the operation, except during sleep and physical therapy times.

This scale was used horizontally before and after 9 cold applications to measure the pain level of the patients.

次要结局

  • The level of satisfaction of patients with the type of cold application applied(,The patient was asked once before discharge (about 1 day after surgery), the level of satisfaction with the type of cold application.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Özge Buldan

Research Assistant

Pamukkale University

研究点 (1)

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